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ENDOSCOPE REPROCESSOR recallZ-0638-2022 · Olympus Corporation of the Americas · initiated Dec 13, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

FDA root cause category: Process control

What the company is doing

Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take: 1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS). 2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that OER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction. If the inspection check passes, you may continue to use your OER-Elite. 3. Access the Olympus recall portal to indicate that you have received this notification and to report the results of the inspection. Go to https://olympusamerica.com/recall. Enter the recall number "0404" and provide your contact information as indicated in the portal. An Olympus Endoscopy Support Specialist (ESS) will reach out to you to schedule an on-site inspection of the OER-Elite detergent and alcohol tubing assembly for final confirmation. If you do not know your local ESS, please contact our Olympus TAC at 1-800-848-9024 to connect you with your local ESS. In addition, if you have further distributed this product, please reach out to those facilities and notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. If you require additional information, please do not hesitate to contact me at [email protected].

Recall details

Recall number
Z-0638-2022
Status
Terminated
Initiated by the company
Dec 13, 2021
Recalling firm
Olympus Corporation of the Americas
Quantity
295 units
Product code
FEB
FDA submissions
K190969, K201920
Distribution
Nationwide

Product description

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

Code information (models, lots, serial numbers)

All serial numbers. UDI: 04953170404047

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

18 devices cleared under K190969, K201920 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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